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Health Canada has granted approval for a groundbreaking drug, donanemab, marketed under the brand name Kisunla by the American pharmaceutical company Eli Lilly. This marks a significant advancement in the fight against Alzheimer’s disease, as it becomes the second treatment aimed at slowing the disease’s progression to receive approval in Canada. The announcement was made on Monday, following the drug’s earlier approval by the U.S. Food and Drug Administration in 2024.
A Step Forward in Alzheimer’s Treatment
Donanemab joins lecanemab, known commercially as Leqembi, which was approved by Health Canada in October 2025. Both medications target amyloid plaques—a sticky protein that accumulates in the brains of individuals in the early stages of Alzheimer’s. The presence of these plaques is associated with cognitive decline, leading to difficulties in memory and thinking.
While donanemab is not a cure, it has shown promise in clinical trials, particularly for those diagnosed in the early phases of the disease. According to the Alzheimer Society of Canada, research suggests that this treatment can significantly slow cognitive decline. In participants who were less advanced in their disease, there was a reported 35 per cent slowdown in decline over 18 months when assessed using the integrated Alzheimer’s Disease Rating Scale (iADRS). The overall population of trial participants experienced a 22 per cent slowdown.
Clinical Findings and Implications
Eli Lilly’s findings reveal that many patients treated with Kisunla were able to cease treatment after their amyloid plaques were cleared; some did so within six months, and nearly half stopped after 12 months. The greatest benefits were observed in early-stage patients, highlighting the importance of timely diagnosis and intervention.
Christina Scicluna, CEO of the Alzheimer Society of Canada, referred to the approval as “a hopeful milestone for people living with early Alzheimer’s and their care partners.” She emphasised the significance of continued research and advocacy, stating, “While not a cure, it shows how far we’ve come and why research and advocacy matters.”
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, echoed this sentiment, articulating that donanemab provides a crucial opportunity for early patients to sustain their independence. “Changing the downward trajectory of Alzheimer’s disease is of the utmost importance,” she asserted. Many individuals in the early stages lead active lives but often face uncertainty about the future.
Regulatory Considerations and Access
Health Canada has stipulated that donanemab will be restricted to adults who do not carry the APOE4 gene—an important genetic factor that heightens the risk of developing dementia and is prevalent in about one-fifth of the global population. Potential side effects associated with the treatment include amyloid-related imaging abnormalities (ARIA), which may manifest as temporary swelling in certain brain areas.
The next step involves Canada’s Drug Agency evaluating whether donanemab should be included in provincial and territorial drug plans. The Alzheimer Society of Canada plans to advocate for public coverage of the drug, although it cautioned that the process of gaining public funding can take up to two years post-regulatory approval. Patients with private insurance may find it easier to access the treatment sooner.
Why it Matters
The approval of donanemab not only represents a critical advancement in Alzheimer’s treatment but also underscores the pressing need for continued support and resources for individuals affected by this debilitating disease. With the potential to improve the quality of life for early-stage patients, this new medication offers hope amid the challenges of navigating Alzheimer’s. As advocacy groups push for equitable access to such treatments, it is imperative that the healthcare system prioritises the needs of those living with Alzheimer’s and their families.
